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World-class professional certification courses in Food Safety, Quality, Science, Technology & Agriculture
About This Course
The FSMA Preventive Controls Qualified Individual (PCQI) Training Course – Version 2 is a comprehensive, competency-based programme designed to equip food industry professionals with the knowledge, practical skills, and regulatory expertise required to develop, implement, validate, and maintain Food Safety Plans that comply with the U.S. Food Safety Modernization Act (FSMA) Preventive Controls for Human Food Rule (21 CFR Part 117). Based on the latest FDA-recognized Version 2 curriculum, this intensive programme emphasizes preventive, risk-based food safety management through hazard analysis, process preventive controls, allergen controls, sanitation controls, supply-chain preventive controls, recall planning, verification, validation, corrective actions, and reanalysis of Food Safety Plans. Through expert-led instruction, real-world case studies, practical workshops, and regulatory scenarios, participants develop the competence to fulfil the responsibilities of a Preventive Controls Qualified Individual (PCQI), strengthen regulatory compliance, enhance audit and inspection readiness, support export to the U.S. market, and build resilient, science-based food safety management systems.
What You’ll Learn
- Develop, implement, validate, and maintain FDA-compliant Food Safety Plans in accordance with the FSMA Preventive Controls for Human Food Rule (21 CFR Part 117) and the latest PCQI Version 2 curriculum.
- Conduct science-based hazard analyses and establish effective preventive controls for process, allergens, sanitation, supply-chain activities, and product recall management.
- Apply risk-based verification, validation, monitoring, corrective action, and Food Safety Plan reanalysis procedures to ensure continual compliance and system effectiveness.
- Fulfil the regulatory responsibilities of a Preventive Controls Qualified Individual (PCQI) by leading Food Safety Plan development, implementation, review, and continuous improvement.
- Prepare organizations for FDA inspections, customer audits, and U.S. export requirements by strengthening preventive food safety systems, regulatory compliance, and operational resilience.
Course Curriculum
- Evolution of the Food Safety Modernization Act (FSMA)
- Preventive Controls for Human Food Rule (21 CFR Part 117)
- Current Good Manufacturing Practices (cGMPs)
- Roles and Responsibilities of the Preventive Controls Qualified Individual (PCQI)
- FDA Compliance, Inspections and Regulatory Expectations
- Components of an FDA-Compliant Food Safety Plan
- Product Description, Intended Use and Consumers
- Process Flow Diagrams and Facility Assessment
- Prerequisite Programmes and Supporting Documentation
- Food Safety Plan Documentation and Record Management
- Biological, Chemical and Physical Hazards
- Radiological Hazards and Economically Motivated Adulteration
- Hazard Identification and Hazard Evaluation
- Determining Hazards Requiring Preventive Controls
- Scientific Justification and Hazard Analysis Documentation
- Process Preventive Control Principles
- Critical Process Parameters and Critical Limits
- Monitoring Process Preventive Controls
- Corrective Actions and Process Deviations
- Verification and Validation of Process Controls
- Food Allergen Hazard Identification
- Allergen Risk Assessment and Management
- Allergen Labelling and Packaging Controls
- Cross-Contact Prevention and Changeover Procedures
- Allergen Verification and Validation Activities
- Environmental Pathogen Control
- Hygienic Zoning and Environmental Monitoring
- Cleaning and Sanitation Programmes
- Sanitation Monitoring and Verification
- Environmental Sampling, Trending and Corrective Actions
- FDA Supply-Chain Program Requirements
- Supplier Approval and Qualification
- Supplier Verification Activities
- Receiving, Ingredient and Raw Material Controls
- Imported Foods and Foreign Supplier Compliance
- Monitoring Procedures and Record Keeping
- Verification Activities and Verification Records
- Validation Requirements for Preventive Controls
- Corrective Actions and Corrections
- Reanalysis of the Food Safety Plan
- FDA Recall Plan Requirements
- Product Coding and Traceability Systems
- Product Withdrawal and Recall Execution
- Crisis Communication and Regulatory Notification
- Mock Recall and Recall Effectiveness Evaluation
- FDA Inspection Process and Investigator Expectations
- Preparing for FDA Inspections
- Inspection Documentation and Evidence Management
- Responding to FDA Form 483 Observations and Warning Letters
- Building a Sustainable FSMA Compliance Programme
- Internal Food Safety System Audits
- Root Cause Analysis and CAPA
- Food Safety Performance Metrics and Trend Analysis
- Management Review and Continuous Improvement
- Food Safety Culture and Organizational Competence
- Developing a Complete FDA-Compliant Food Safety Plan
- Comprehensive Hazard Analysis Workshop
- Preventive Controls Design and Validation Exercise
- Mock FDA Regulatory Inspection and Compliance Assessment
- Final Competency Assessment and Executive Food Safety Plan Presentation
Who Should Attend
- Food Safety, Quality Assurance, HACCP, and FSMS professionals responsible for developing and maintaining Food Safety Plans under FSMA.
- Technical Managers, Production Managers, Operations Leaders, and Plant Supervisors overseeing preventive food safety controls and regulatory compliance.
- Preventive Controls Qualified Individuals (PCQIs), Internal Auditors, Regulatory Affairs, and Compliance professionals seeking to strengthen implementation and inspection readiness.
- Food manufacturers, processors, ingredient suppliers, exporters, and organizations supplying or intending to supply the U.S. market.
- Food safety consultants, trainers, certification professionals, and regulatory personnel supporting FSMA compliance and preventive controls implementation.
Prerequisites
- This programme is suitable for both new and experienced professionals seeking to develop FDA-compliant Food Safety Plans and fulfil the responsibilities of a Preventive Controls Qualified Individual (PCQI).
- Prior experience in food production or Food Safety Management Systems is advantageous but not essential.
Key Benefits
- Develop FDA-compliant Food Safety Plans that meet FSMA Preventive Controls for Human Food requirements and strengthen regulatory compliance.
- Build the competence to perform the responsibilities of a Preventive Controls Qualified Individual (PCQI) using the latest FDA-recognized Version 2 framework.
- Strengthen preventive food safety systems through robust hazard analysis, preventive controls, verification, validation, and risk-based decision-making.
- Improve FDA inspection readiness, audit performance, and compliance with customer and international market requirements, including U.S. export expectations.
- Enhance organizational resilience, reduce food safety risks, and foster a proactive culture of continual improvement, regulatory excellence, and consumer protection.
Delivery Technique
- Expert-led facilitation based on the latest FDA-recognized PCQI Version 2 curriculum and FSMA regulatory requirements.
- Interactive workshops focused on Food Safety Plan development, hazard analysis, and preventive controls implementation.
- Practical case studies, regulatory scenarios, and risk assessment exercises reflecting real food manufacturing environments.
- Hands-on Food Safety Plan development, verification, validation, and FDA inspection readiness simulations.
- Collaborative group discussions, implementation exercises, and facilitator coaching to support immediate workplace application.